Some philosophy [Power / Sample Size]

posted by BE-proff – 2015-12-26 17:44 (3830 d 16:06 ago) – Posting: # 15767
Views: 6,555

Hi All,

If to conduct a BE-study with alfa error 5% and power 80% it means that a customer has 5% risk to buy non-BE medication and a developer has 20% risk to reject bioequivalent drug.

So, if we failed BE-study because PK-parameters were out of acceptance range may be we were "unlucky" and fall into 20% risk? :confused:

I wonder if there are any ways to decrease risk except sample sizing? :confused:

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
131 visitors (0 registered, 131 guests [including 33 identified bots]).
Forum time: 10:51 CEST (Europe/Vienna)

Scientists cannot simply hang their subjectivities
up on a hook outside the laboratory door.    Ruth Bleier

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5